FDA Product Code NVP: Holding Chambers, Direct Patient Interface
Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Dispensed Medication. Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles
Leading manufacturers include Trudell Medical Intl., Thayer Medical Corporation and Trudell Medical International.
16
Total
16
Cleared
247d
Avg days
2005
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
132d
recently vs 255d historically
FDA 510(k) Cleared Holding Chambers, Direct Patient Interface Devices (Product Code NVP)
16 devices
Cleared
Jan 15, 2025
AeroChamber2go Anti-Static Valved Holding Chamber
Trudell Medical International
Anesthesiology
132d
Cleared
Apr 01, 2022
LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber
Thayer Medical Corporation
Anesthesiology
400d
Cleared
Jan 11, 2019
AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
Trudell Medical International
Anesthesiology
203d
Cleared
May 19, 2017
Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber
Thayer Medical Corporation
Anesthesiology
486d
Cleared
Jan 26, 2016
Antistatic Compact Space Chamber
Medical Developments International Limited
Anesthesiology
403d
Cleared
Oct 03, 2014
FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
Fsc Laboratories, Inc.
Anesthesiology
266d
Cleared
Nov 13, 2013
SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
Medical Developments International
Anesthesiology
474d
Cleared
Jun 05, 2013
INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER
Inspirx, Inc.
Anesthesiology
90d
Cleared
Jul 11, 2012
AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)
Trudell Medical Intl.
Anesthesiology
363d
Cleared
Aug 09, 2011
OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER
Respironics New Jersey, Inc.
Anesthesiology
189d
Cleared
Apr 29, 2011
AGACHAMBER SPACER
Aga Plastic Ind. Com. Ltda.
Anesthesiology
351d
Cleared
Apr 18, 2011
RESPICHAMBER VALVED HOLDING CHAMBER
Trudell Medical Intl.
Anesthesiology
90d
Cleared
Jan 28, 2011
FISIO CHAMBER SPACE
Koo (Shanghai) Industries Co., Ltd.
Anesthesiology
281d
Cleared
Jun 30, 2008
WATCHHALER
Activaero America, Inc.
Anesthesiology
168d
Cleared
Apr 11, 2007
AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR
Trudell Medical Intl.
Anesthesiology
30d
Cleared
Sep 21, 2005
AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER
Trudell Medical Intl.
Anesthesiology
26d
About Product Code NVP - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code NVP since 2005, with 16 receiving FDA clearance (average review time: 247 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - NVP Product Code
Recent submissions under NVP have taken an average of 132 days to reach a decision - down from 255 days historically, suggesting improved FDA processing for this classification.
NVP devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →